The main research interests of the Unit include: (a) pharmacoepidemiology,
oriented to describe the beneficial and harmful effects of psychotropic drugs
in ordinary practice; (b) randomized controlled trials, oriented to assess the
efficacy and tolerability profile of psychotropic drugs in experimental
conditions; (c) systematic reviews, oriented to summarize clinical trial
findings using meta-analytical techniques. Recent achievements of the Unit
include the development of a psychotropic register that collects information on
psychotropic drugs prescribed within the South-Verona catchment area; the
development of a network of psychiatric services that is currently recruiting
patients for a multi-centre randomized controlled trial; the production of
systematic reviews in the field of antidepressants and antipsychotics; and the
development of tools oriented to assist the World Health Organization to
improve the rational use of psychotropic drugs in low and middle income
countries. The projects of the Unit are financially supported by organisations
not linked with drug companies..

CHAT Study:
CHAT (Clozapine, Haloperidol, Aripiprazole Trial) is a prospective, multicentre,
randomized, parallel-group, superiority trial that compares the efficacy and
tolerability of combination treatment with clozapine plus aripiprazole versus
combination treatment with clozapine plus haloperidol in patients with
schizophrenia who do not have an optimal response to clozapine. Consecutive
patients with an incomplete response to treatment with clozapine over an
appropriate period of time are randomly assigned to augmentation with
aripiprazole or haloperidol. These patients constitute the randomised cohort.
Patients with an incomplete response to treatment with clozapine over an
appropriate period of time, who are not randomly assigned to competitive
treatments, are followed under real-world circumstances. These patients
constitute the observational cohort. In both the experimental and observational
cohort patients and clinicians are not blind to pharmacological treatments
provided during the trial. Withdrawal from allocated treatment within three
months is the primary outcome. Secondary outcomes include severity of symptoms
on the Brief Psychiatric Rating Scale (BPRS) and antipsychotic subjective
tolerability on the Liverpool University Neuroleptic Side Effect Rating Scale
(LUNSERS). The study is now concluded and statistical analysis to review the
data are ongoing.

LAST- RD Study:
LAST-RD (Lithium And Standard Therapy in Resistant Depression) is a
prospective, multicentre, randomized, parallel-group, superiority trial that
will follow patients over a period of 12 months. Patients with
treatment-resistant depression and risk of suicide will be randomly assigned to
(i) lithium plus usual pharmacological and non-pharmacological treatment or to
(ii) usual pharmacological and non-pharmacological treatment. Patients and
clinicians will not be blind to pharmacological treatments provided during the
trial. In order to limit the potential bias introduced by lack of blindness, an
independent adjudicating committee, blind to treatment allocation, will
validate the events that will constitute the primary outcome. Patients will be
assessed at baseline before randomization and then every month after random
allocation until the completion of the 12-month follow-up. All phases of the
trial will be recorded following the CONSORT statement.

SUBJECTIVE
PERCEPTION OF ANTIPSYCHOTIC DRUGS
Almost no data are available on whether patients and doctors have similar or
dissimilar opinions on the presence and level of distress of antipsychotic
adverse effects. This project was therefore undertaken to compare doctors'
versus patients' perspective on the presence and level of distress of antipsychotic
adverse effects in a sample of patients under the care of the South-Verona
mental health services. All patients exposed to antipsychotic drugs during a
census period of 6 months were identified. For each included subject,
socio-demographic, clinical and treatment data were extracted. Patients'
perspective on antipsychotic adverse effects was measured by means of the
Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). The
LUNSERS was similarly employed to measure doctors' perspective on antipsychotic
adverse effects. During the recruitment period, more than 200 patients taking
antipsychotic drugs were enrolled in the survey. Preliminary findings, which
showed that the correlation between the total LUNSERS score reported by
patients and doctors was very low, indicate that doctors, researchers and
health care providers should increasingly consider patient and doctor
perspectives as two complementary dimensions that may provide different
insights in the evaluation of antipsychotic drugs.